Cognitive Training Program for Individuals With Depression and Post-Traumatic Stress Disorder

Major Depressive Disorder Clinical Trial

Official title:

Investigating the Efficacy of a Top-Down Approach to Cognitive Remediation in Individuals With Affective Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02502604
• Other study ID #: 0416
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: August 2018

Study information

• Verified date: February 2021
• Source: St. Joseph's Healthcare Hamilton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Individuals with affective disorders (including post-traumatic stress disorder (PTSD) and major depressive disorder (MDD)) often experience declines in cognitive abilities such as memory and attention. Such difficulties can reduce functioning in important aspects of life, including at work or school. Little research has been conducted to investigate if cognitive dysfunction can be reduced in individuals with PTSD or MDD following a specific treatment. Thus, the investigators plan to determine the utility of a cognitive training program called goal management training (GMT) in reducing cognitive dysfunction in MDD/PTSD. GMT aims to assist participants in building skills in performing specific behaviours that rely on basic cognitive processes, allowing them to achieve an identified goal. 64 individuals with PTSD and 64 with MDD will be divided into two groups of 32, one GMT group, and one wait-list group that will receive GMT after study completion. The investigators predict that in comparison to the wait-list group, the GMT group will show greater improvements in cognitive functioning and everyday functioning following treatment and that these improvements will remain long-term.

Description:

In addition to their core affective components, MDD and PTSD are associated with poor cognitive functioning across a host of highly similar domains, including declarative memory, short-term memory, attention, and executive functioning. These deficits have been associated with reduced response to pharmacological and non-pharmacological interventions and poor functional outcomes. Given the potentially devastating impact of poor cognitive functioning on the ability of patients with affective disorders to benefit from treatment interventions, and its association with poor functional outcomes, there is an urgent need to identify novel treatment interventions aimed at reducing cognitive dysfunction in these disorders. Accordingly, the aim of the present proposal is to a randomized controlled trial examining the efficacy of a well-established cognitive intervention aimed at reducing attentional and executive dysfunction, Goal Management Training® (GMT), in the treatment of cognitive deficits among patients with MDD and with PTSD. A secondary aim is to determine the longer-term impact of this approach on functional outcomes.

Importantly, limited investigation of cognitive remediation therapy has been performed in these populations. Only one study has been conducted to examine the impact of a non-standardized intervention protocol aimed at improving cognitive functioning in PTSD. Here, clinically (but not statistically) significant improvements were noted in a small pilot study on measures of cognitive functioning after employing bottom-up executive training approach in conjunction with transcranial direct current sample of four patients. Previously, the investigators have applied computer-assisted cognitive remediation, a bottom-up restitution based approach, in patients with MDD, resulting in improvements in performance on working memory tasks in conjunction with increased functional activity in lateral prefrontal and parietal areas, however, the broad benefits of this training observed in a small sample (n=12) did not generalize to a larger group.

GMT has demonstrated efficacy in several clinical and non-clinical populations that experience deficits in executive functioning, attention, and memory (similar to those seen in MDD and PTSD), including older adults, individuals who have suffered a traumatic brain injury, have attention-deficit hyperactivity disorder (ADHD), poly-substance abuse disorder, or spina bifida. In these studies, participants showed improvements in completing every-day tasks (as measured by self-report), as well as improvements in executive functions such as decision-making, working memory and selective attention. Critically, these results were maintained at follow-up (when assessed). Given the previous success of this intervention in remediating frontal-temporally mediated brain dysfunction across clinical populations, the investigators hypothesize that GMT has the ability to target similar cognitive difficulties experienced by those suffering from MDD and from PTSD. The investigators will further examine whether putative improvements in cognitive performance will translate to functional improvements analogous to those seen in other psychiatric populations undergoing cognitive remediation.

In the current study, the investigators will conduct the first study to investigate the utility of GMT in patients with MDD or with PTSD. Specifically, the primary aim of this proposed study is to examine whether a standardized 9-week program of GMT results in durable improvements in cognitive functioning relative to a wait-list control (WLC). A secondary aim will be to determine whether participation in the GMT group is associated with long-term functional improvements. The investigators hypothesize that at post-treatment, participants with MDD and with PTSD assigned to the GMT groups will show significantly greater improvement in neuropsychological test performance and greater functional improvement compared to participants in the WLC group; these gains are expected to be maintained at 3 month follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Structured Clinical Interview for DSM-IV-TR for Axis I Disorders (SCID-I (First et al., 1996))-confirmed primary diagnosis of MDD or PTSD

2. between the age of 18-60

3. able to provide written informed consent.

Exclusion Criteria:

1. Receiving treatment with anti-cholinergic or anti-psychotic medication

2. have had electroconvulsive therapy within the past year

3. a history of substance dependence or significant and recent (< 1 year) substance abuse)

4. a recent history (within the past 12 months) of medical disorder known to adversely affect cognition

5. loss of consciousness greater than 1 minute or a history of traumatic brain injury

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Goal Management Training
Goal management training sessions will be 2 hours in length and focus on learning skills that will assist in planning, carrying out, and monitoring goal-directed behaviours.

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

References & Publications (14)

Alfonso JP, Caracuel A, Delgado-Pastor LC, Verdejo-García A. Combined Goal Management Training and Mindfulness meditation improve executive functions and decision-making performance in abstinent polysubstance abusers. Drug Alcohol Depend. 2011 Aug 1;117(1):78-81. doi: 10.1016/j.drugalcdep.2010.12.025. Epub 2011 Feb 1. — View Citation

Altshuler LL, Bearden CE, Green MF, van Gorp W, Mintz J. A relationship between neurocognitive impairment and functional impairment in bipolar disorder: a pilot study. Psychiatry Res. 2008 Jan 15;157(1-3):289-93. Epub 2007 Sep 14. — View Citation

Dunkin JJ, Leuchter AF, Cook IA, Kasl-Godley JE, Abrams M, Rosenberg-Thompson S. Executive dysfunction predicts nonresponse to fluoxetine in major depression. J Affect Disord. 2000 Oct;60(1):13-23. — View Citation

Elgamal S, McKinnon MC, Ramakrishnan K, Joffe RT, MacQueen G. Successful computer-assisted cognitive remediation therapy in patients with unipolar depression: a proof of principle study. Psychol Med. 2007 Sep;37(9):1229-38. Epub 2007 Jul 5. — View Citation

In de Braek DMJM, Dijkstra JB, Ponds RW, Jolles J. Goal Management Training in Adults With ADHD: An Intervention Study. J Atten Disord. 2017 Nov;21(13):1130-1137. doi: 10.1177/1087054712468052. Epub 2012 Dec 20. — View Citation

Jaeger J, Vieta E. Functional outcome and disability in bipolar disorders: ongoing research and future directions. Bipolar Disord. 2007 Feb-Mar;9(1-2):1-2. — View Citation

Krasny-Pacini A, Limond J, Evans J, Hiebel J, Bendjelida K, Chevignard M. Context-sensitive goal management training for everyday executive dysfunction in children after severe traumatic brain injury. J Head Trauma Rehabil. 2014 Sep-Oct;29(5):E49-64. doi: 10.1097/HTR.0000000000000015. — View Citation

Levine B, Robertson IH, Clare L, Carter G, Hong J, Wilson BA, Duncan J, Stuss DT. Rehabilitation of executive functioning: an experimental-clinical validation of goal management training. J Int Neuropsychol Soc. 2000 Mar;6(3):299-312. — View Citation

Levine B, Schweizer TA, O'Connor C, Turner G, Gillingham S, Stuss DT, Manly T, Robertson IH. Rehabilitation of executive functioning in patients with frontal lobe brain damage with goal management training. Front Hum Neurosci. 2011 Feb 17;5:9. doi: 10.3389/fnhum.2011.00009. eCollection 2011. — View Citation

Levine B, Stuss DT, Winocur G, Binns MA, Fahy L, Mandic M, Bridges K, Robertson IH. Cognitive rehabilitation in the elderly: effects on strategic behavior in relation to goal management. J Int Neuropsychol Soc. 2007 Jan;13(1):143-52. — View Citation

Marazziti D, Consoli G, Picchetti M, Carlini M, Faravelli L. Cognitive impairment in major depression. Eur J Pharmacol. 2010 Jan 10;626(1):83-6. doi: 10.1016/j.ejphar.2009.08.046. Epub 2009 Oct 14. Review. — View Citation

Polak AR, Witteveen AB, Reitsma JB, Olff M. The role of executive function in posttraumatic stress disorder: a systematic review. J Affect Disord. 2012 Dec 1;141(1):11-21. doi: 10.1016/j.jad.2012.01.001. Epub 2012 Feb 5. Review. — View Citation

Saunders N, Downham R, Turman B, Kropotov J, Clark R, Yumash R, Szatmary A. Working memory training with tDCS improves behavioral and neurophysiological symptoms in pilot group with post-traumatic stress disorder (PTSD) and with poor working memory. Neurocase. 2015;21(3):271-8. doi: 10.1080/13554794.2014.890727. Epub 2014 Feb 28. — View Citation

Stubberud J, Langenbahn D, Levine B, Stanghelle J, Schanke AK. Goal management training of executive functions in patients with spina bifida: a randomized controlled trial. J Int Neuropsychol Soc. 2013 Jul;19(6):672-85. doi: 10.1017/S1355617713000209. Epub 2013 Apr 11. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Psychiatric diagnosis on the Structured Clinical Interview for DSM-IV - Text Revision	Assesses axis I disorders from the DSM-IV.	Baseline
Primary	Verbal and Phonemic Fluency on the Controlled Oral Word Association Task		Change from baseline to 9 week and 3 month follow-ups.
Primary	Processing speed and response inhibition on the Stoop Colour and Word Test		Change from baseline to 9 week and 3 month follow-ups.
Primary	Attention alternation on the Trail Making Test Part B		Change from baseline to 9 week and 3 month follow-ups.
Primary	Forming and shifting concepts on the Wisconsin Card Sorting Task		Change from baseline to 9 week and 3 month follow-ups.
Primary	Processing speed on the Weschler Adult Intelligence Scale IV - Symbol Coding subtest		Change from baseline to 9 week and 3 month follow-ups.
Primary	Inattentiveness, impulsivity, sustained attention and vigilance on Connors Continuous Performance Task		Change from baseline to 9 week and 3 month follow-ups.
Primary	Working memory on the N-back Task	Measures ability to maintain and manipulate auditory information in memory.	Change from baseline to 9 week and 3 month follow-ups.
Primary	Immediate and delayed memory, interference learning and recognition on the California Verbal Learning Test II		Change from baseline to 9 week and 3 month follow-ups.
Primary	Contextually based memory on the Weschler Memory Scale III - Logical Memory		Change from baseline to 9 week and 3 month follow-ups.
Primary	Nonverbal visuospatial memory on the Brief Visuospatial Memory Test - Revised		Change from baseline to 9 week and 3 month follow-ups.
Primary	Current intellectual functioning on the Weschler Abbreviated Scale of Intelligence - II		Baseline
Primary	Pre-morbid intellectual functioning on the National Adult Reading Test		Baseline
Primary	Self-reported executive difficulties on the Dysexecutive Questionnaire		Change from baseline to 9 week and 3 month follow-ups.
Primary	Self reported daily errors in distractibility, blunders, and memory on the Cognitive Failures Questionnaire		Change from baseline to 9 week and 3 month follow-ups.
Primary	Self reported work, education, and residential functioning on the Multidimensional Scale of Independent Functioning		Change from baseline to 9 week and 3 month follow-ups.
Primary	Disability in work, social relationships, and family life on the Sheehan Disability Scale		Change from baseline to 9 week and 3 month follow-ups.
Primary	Functional competence on the Canadian Objective Assessment of Life Skills - Brief Version		Change from baseline to 9 week and 3 month follow-ups.
Secondary	Current PTSD symptomatology on the Clinician Administered PTSD Scale for DSM 5		Change from baseline to 9 week and 3 month follow-ups.
Secondary	Exposure ot childhood trauma on the Childhood Trauma Questionnaire		Baseline
Secondary	Dissociative symptoms on the Multiscale Dissociation Inventory		Change from baseline to 9 week and 3 month follow-ups.
Secondary	Current depressive symptomatology on the Beck Depression Inventory - II		Change from baseline to 9 week and 3 month follow-ups.
Secondary	Current anxiety symptomatology on the Beck Anxiety Inventory		Change from baseline to 9 week and 3 month follow-ups.